Method and system of quick neurostimulation electrode configuration and positioning

ABSTRACT

A model of an implantable lead is provided via a graphical user interface. The implantable lead is configured to deliver electrical stimulation to a patient via a plurality of electrodes located on the implantable lead. The graphical user interface also provides a plurality of predefined electrode activation patterns that include a coarse pattern and a refined pattern. The coarse pattern corresponds to a first group of electrodes located in a first region of the implantable lead. The refined pattern corresponds to a second group of electrodes located in a second region of the implantable lead. The second region is smaller than, and is a subsection of, the first region. A coarse testing process is performed by selectively activating the first group of electrodes belonging to the coarse pattern. Thereafter, a refined testing process is performed by selectively activating the second group of electrodes belonging to the refined pattern.

PRIORITY DATA

The present application is a continuation application of U.S. patentapplication Ser. No. 13/973,316, filed on Aug. 22, 2013, which is autility application of provisional U.S. Patent Application No.61/695,439, filed on Aug. 31, 2012, entitled “Method and System of QuickNeurostimulation Electrode Configuration and Positioning,” and a utilityapplication of provisional U.S. Patent Application No. 61/824,296, filedon May 16, 2013, entitled “Features and Functionalities of an AdvancedClinician Programmer,” the disclosure of each of which is herebyincorporated by reference in its entirety.

BACKGROUND

As medical device technologies continue to evolve, active implantedmedical devices have gained increasing popularity in the medical field.For example, one type of implanted medical device includesneurostimulator devices, which are battery-powered or battery-lessdevices that are designed to deliver electrical stimulation to apatient. Through proper electrical stimulation, the neurostimulatordevices can provide pain relief for patients or restore bodilyfunctions.

Implanted medical devices (for example a neurostimulator) can becontrolled using an electronic programming device such as a clinicianprogrammer or a patient programmer. These programmers can be used bymedical personnel or the patient to define the particular electricalstimulation therapy to be delivered to a target area of the patient'sbody, alter one or more parameters of the electrical stimulationtherapy, or otherwise conduct communications with a patient.

Despite many advances made in the field of neurostimulation, onedrawback is that the electronic programmers such as the clinicianprogrammer have not been used to increase the efficiency of processescarried out during an actual implant procedure. For example, one of suchprocesses carried out during an implant procedure involves testingpulses along the length of an implant lead, which is a device implantednext to the spinal cord containing the electrodes that deliver theelectrical pulses. This process is used to determine what areas of thespinal cord need to be stimulated in order to mitigate the patient'spain, and how the lead needs to be positioned accordingly. Currently, aclinician (or another healthcare professional) would have to select oneor more particular electrodes on the lead for manual programming,execute the stimulation, and wait for patient feedback. Based on thepatient feedback, the clinician would have to adjust the positioning ofthe lead and repeat the entire process again. The process may need to berepeated several times before the clinician has found a lead positionand electrode configuration that are deemed to be satisfactory.Therefore, the process discussed above is time-consuming, which isundesirable given that the process is performed in an operating roomduring an actual surgery. Among other things, the long process time maylead to more patient discomfort and increases the risks of the surgery.In other words, any procedure that takes place in a surgical setting istime critical. Since the lead position and electrode configurationprocess takes place during such surgical setting, it is imperative thatit be fast, which unfortunately is not the case with existingprogrammers.

Therefore, although existing electronic programmers used forneurostimulation have been generally adequate for their intendedpurposes, they have not been entirely satisfactory in every aspect.

SUMMARY

One aspect of the present disclosure involves a system for determiningelectrode configuration and positioning for neurostimulation. Theelectronic device comprises: a memory storage component configured tostore programming code; and a computer processor configured to executethe programming code to perform the following tasks: providing a virtualrepresentation of an implant lead, the implant lead being configured todeliver electrical stimulation to a patient via one or more of aplurality of electrodes located on the implant lead; providing apredefined electrode activation pattern that identifies a plurality ofsubsets of the electrodes that can be activated one subset at a time,wherein the electrodes in each subset are programmed with theirrespective electrical stimulation parameters; and activating the subsetsof the electrodes one subset at a time, wherein each activated subset ofelectrodes delivers electrical stimulation to a different region of aspine of the patient.

Another aspect of the present disclosure involves a medical system. Themedical system includes: an implantable lead configured to deliverelectrical stimulation to a patient via one or more of a plurality ofelectrodes located on the implantable lead; and a portable electronicprogrammer on which a touch-sensitive user interface is implemented,wherein the user interface is configured to: provide a virtualrepresentation of the implantable lead; provide a predefined electrodeactivation pattern that identifies a plurality of subsets of theelectrodes on the implantable lead that can be activated one subset at atime, wherein the electrodes in each subset are programmed with theirrespective electrical stimulation parameters; and activate the subsetsof the electrodes one subset at a time, wherein each activated subset ofelectrodes delivers electrical stimulation to a different region of aspine of the patient.

Yet another aspect of the present disclosure involves a method ofdetermining electrode configuration and positioning forneurostimulation. The method comprises: providing a virtualrepresentation of an implant lead, the implant lead being configured todeliver electrical stimulation to a patient via one or more of aplurality of electrodes located on the implant lead; providing apredefined electrode activation pattern that identifies a plurality ofsubsets of the electrodes that can be activated one subset at a time,wherein the electrodes in each subset are programmed with theirrespective electrical stimulation parameters; and activating the subsetsof the electrodes one subset at a time, wherein each activated subset ofelectrodes delivers electrical stimulation to a different region of aspine of the patient.

One more aspect of the present disclosure involves an electronicapparatus for determining electrode configuration and positioning forneurostimulation. The electronic apparatus comprises: input/output meansfor communicating with a user, the input/output means including atouch-sensitive screen configured to detect an input from the user anddisplay an output to the user; memory storage means for storingexecutable instructions; and computer processor means for executing theinstructions to perform the following tasks: providing a virtualrepresentation of an implant lead, the implant lead being configured todeliver electrical stimulation to a patient via one or more of aplurality of electrodes located on the implant lead; providing apredefined electrode activation pattern that identifies a plurality ofsubsets of the electrodes that can be activated one subset at a time,wherein the electrodes in each subset are programmed with theirrespective electrical stimulation parameters; and activating the subsetsof the electrodes one subset at a time, wherein each activated subset ofelectrodes delivers electrical stimulation to a different region of aspine of the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects of the present disclosure are best understood from the followingdetailed description when read with the accompanying figures. It isemphasized that, in accordance with the standard practice in theindustry, various features are not drawn to scale. In fact, thedimensions of the various features may be arbitrarily increased orreduced for clarity of discussion. In the figures, elements having thesame designation have the same or similar functions.

FIG. 1 is a simplified block diagram of an example medical environmentin which evaluations of a patient may be conducted according to variousaspects of the present disclosure.

FIGS. 2, 3A-3D, and 5-7 are embodiments of a user interface fordetermining electrode configuration and positioning for neurostimulationaccording to various aspects of the present disclosure.

FIG. 4 is a simplified illustration of an electronic patient feedbackdevice.

FIGS. 8-9 are simplified flowcharts illustrating a method of determiningelectrode configuration and positioning for neurostimulation accordingto various aspects of the present disclosure.

FIG. 10 is a simplified block diagram of an electronic programmeraccording to various aspects of the present disclosure.

FIG. 11 is a simplified block diagram of an implantable medical deviceaccording to various aspects of the present disclosure.

FIG. 12 is a simplified block diagram of a medical system/infrastructureaccording to various aspects of the present disclosure.

FIGS. 13A and 13B are side and posterior views of a human spine,respectively.

DETAILED DESCRIPTION

It is to be understood that the following disclosure provides manydifferent embodiments, or examples, for implementing different featuresof the invention. Specific examples of components and arrangements aredescribed below to simplify the present disclosure. These are, ofcourse, merely examples and are not intended to be limiting. Variousfeatures may be arbitrarily drawn in different scales for simplicity andclarity.

The use of active implanted medical devices has become increasinglyprevalent over time. Some of these implanted medical devices includeneurostimulator devices that are capable of providing pain relief bydelivering electrical stimulation to a patient. In that regards,electronic programmers have been used to configure or program theseneurostimulators (or other types of suitable active implanted medicaldevices) so that they can be operated in a certain manner. Theseelectronic programmers include clinician programmers and patientprogrammers, each of which may be a handheld device. For example, aclinician programmer allows a medical professional (e.g., a doctor or anurse) to define the particular electrical stimulation therapy to bedelivered to a target area of the patient's body, while a patientprogrammer allows a patient to alter one or more parameters of theelectrical stimulation therapy.

In recent years, these electronic programmers have achieved significantimprovements, for example, improvements in size, power consumption,lifetime, and ease of use. Despite these advances, electronicprogrammers have not been used to increase the efficiency of performingcertain procedures in the field of neurostimulation. For instance,healthcare professionals may need to perform a process of testingelectrode patterns for implant lead positioning to determine the exactplacement of an implant lead. In more detail, during/after the leadimplantation, the healthcare professional programs pulses on theclinician programmer. This programming includes a set of the electrodespicked by the healthcare professional from experience or by guessing(which electrodes are to be anodes and cathodes and in what timesequence). After the pulses have been programmed, the healthcareprofessional activates stimulation using the clinician programmer. Thepatient gives feedback regarding the effect of the stimulation verbally,and the healthcare professional adjusts the position of the lead or theelectrode set accordingly. The patient continues giving feedback, andthe healthcare professional continues adjusting the pattern andpositioning until the results are satisfactory (e.g., pain isminimized). However, this is a time-consuming process that takes placeduring actual surgery, which is undesirable. In general, any procedurethat takes place in a surgical setting is time critical (i.e., needs tobe performed fast). A long time delay during surgery may increasesurgery risks and/or patient discomfort. Since the lead position andelectrode configuration process discussed above takes place during suchsurgical setting, a versatile electronic programmer should be able toperform this process very quickly. Unfortunately, existing programmershave not been able to offer a satisfactory solution to perform suchprocess quickly.

To address the issues discussed above, the present disclosure offers amethod and system of quick neurostimulation electrode configuration andpositioning via an electronic programmer such as the clinicianprogrammer, as discussed below in more detail.

FIG. 1 is a simplified block diagram of a medical device system 20 isillustrated to provide an example context of the various aspects of thepresent disclosure. The medical system 20 includes an implantablemedical device 30, an external charger 40, a patient programmer 50, anda clinician programmer 60. The implantable medical device 30 can beimplanted in a patient's body tissue. In the illustrated embodiment, theimplantable medical device 30 includes an implanted pulse generator(IPG) 70 that is coupled to one end of an implanted lead 75. The otherend of the implanted lead 75 includes multiple electrode surfaces 80through which electrical current is applied to a desired part of a bodytissue of a patient. The implanted lead 75 incorporates electricalconductors to provide a path for that current to travel to the bodytissue from the IPG 70. Although only one implanted lead 75 is shown inFIG. 1, it is understood that a plurality of implanted leads may beattached to the IPG 70.

Although an IPG is used here as an example, it is understood that thevarious aspects of the present disclosure apply to an external pulsegenerator (EPG) as well. An EPG is intended to be worn externally to thepatient's body. The EPG connects to one end (referred to as a connectionend) of one or more percutaneous, or skin-penetrating, leads. The otherend (referred to as a stimulating end) of the percutaneous lead isimplanted within the body and incorporates multiple electrode surfacesanalogous in function and use to those of an implanted lead.

The external charger 40 of the medical device system 20 provideselectrical power to the IPG 70. The electrical power may be deliveredthrough a charging coil 90. In some embodiments, the charging coil canalso be an internal component of the external charger 40. The IPG 70 mayalso incorporate power-storage components such as a battery or capacitorso that it may be powered independently of the external charger 40 for aperiod of time, for example from a day to a month, depending on thepower requirements of the therapeutic electrical stimulation deliveredby the IPG.

The patient programmer 50 and the clinician programmer 60 may beportable handheld devices that can be used to configure the IPG 70 sothat the IPG 70 can operate in a certain way. The patient programmer 50is used by the patient in whom the IPG 70 is implanted. The patient mayadjust the parameters of the stimulation, such as by selecting aprogram, changing its amplitude, frequency, and other parameters, and byturning stimulation on and off. The clinician programmer 60 is used by amedical personnel to configure the other system components and to adjuststimulation parameters that the patient is not permitted to control,such as by setting up stimulation programs among which the patient maychoose, selecting the active set of electrode surfaces in a givenprogram, and by setting upper and lower limits for the patient'sadjustments of amplitude, frequency, and other parameters.

In the embodiments discussed below, the clinician programmer 60 is usedas an example of the electronic programmer. However, it is understoodthat the electronic programmer may also be the patient programmer 50 orother touch screen programming devices (such as smart-phones or tabletcomputers) in other embodiments.

FIGS. 2-3 and 5-7 illustrate an example user interface 100 of anembodiment of the clinician programmer 60. The user interface 100 isintended for a target user, which may be a healthcare professional, forexample a surgeon. The user and the healthcare professional areinterchangeably referred in the following paragraphs, but it isunderstood that they need not necessarily be the same entity.

Referring to FIG. 2, the user interface 100 displays a virtualrepresentation of an anatomical environment 105 in which a lead isimplanted. In the illustrated embodiment, the anatomical environment 105includes a virtual representation of a portion of a spine 110(representing the spine of the patient undergoing the surgery), as wellas a virtual representation of a lead 115 shown with respect to thespine 110. The lead 115 may be an embodiment of the lead 75 shown inFIG. 1, or any other suitable implantable lead. The anatomicalenvironment 105 also includes a virtual representation of an implantablepulse generator 120 as an embodiment of the implantable medical device30 shown in FIG. 1.

The user interface 100 also illustrates another virtual representationof the lead 115A in greater detail. For example, the lead 115A is a 2×6lead and contains two columns and six rows of electrodes 125. Each ofthe electrodes 125 can be individually programmed with its own set ofstimulation parameters in order to deliver electrical stimulation to anearby nerve tissue. These stimulation parameters include, but are notlimited to, electrical current amplitude, pulse width, frequency, andelectrode polarity (anode/cathode).

The user interface 100 further illustrates an electrode pattern menu 130(also referred to an electrode pattern library). The menu 130 contains aplurality of preset or predefined electrode activation patterns 140,such as patterns 140A and 140B shown herein. The electrode activationpatterns 140 each identify a plurality of subsets of the electrodes 125that are to be activated one subset at a time (discussed in more detailbelow). In the illustrated embodiment, the electrode activation pattern140A is selected, which corresponds to four subsets of electrodes 125 onthe lead 115 to be activated: electrodes 125A and 125B as a firstsubset, electrodes 125C and 125D as a second subset, electrodes 125E and125F as a third subset, and electrodes 125G and 125H as a fourth subset.To clearly illustrate which electrodes 125 belong to which subset, thesubsets of electrodes 125 are segregated from one another with virtualdividers (illustrated herein as lines) 145 in the user interface 100.

As discussed above, the electrodes 125 in each subset may be programmedwith their own stimulation parameters. The stimulation parameterprogramming may be set as default values by the user interface 100 insome embodiments. In other embodiments, a user may enter in thestimulation parameters through a different part of the user interface,for example in accordance with U.S. patent application Ser. No.13/601,631, filed on Aug. 31, 2012, and entitled “Programming andVirtual Reality Representation of Stimulation Parameter Groups” toNorbert Kaula, et al., attorney docket No. QIG 099/46901.27, thecontents of which are hereby incorporated by reference in its entirety.It is understood that the stimulation parameters may be set beforesurgery (to implant the lead) takes place, or they may be set oradjusted during surgery. In certain embodiments, the stimulationparameters may also be set or adjusted post-surgery, for example in afollow-up visit. Some of these stimulation parameters may also bedisplayed in the user interface 100 as text. The electrode polarity ofeach electrode may be indicated by a particular color, for example bluefor a cathode and green for an anode, or vice versa.

It is understood that the electrodes 125 included in the electrodeactivation patterns 140 may not necessarily include all the availableelectrodes 125 on the lead 115A. For example, in the illustratedembodiment, though the lead 115A includes a total of twelve electrodes,only eight of such electrodes 125A-125H are identified in the electrodeactivation patterns 140A and 140B. This is done to save precious testingtime in an electrode configuration and positioning process discussedbelow. In some embodiments, the subsets of electrodes identified by theelectrode activation patterns 140 are spaced apart from adjacent subsetsas much as feasible. In this manner, the subsets of electrodes 125 maystill “cover” the length of the lead 115 with a minimum number ofelectrodes.

In certain embodiments, some of the electrode activation patterns may beset up so that only electrodes from a limited portion (e.g., the tophalf) of the lead 115A are included. These patterns may be referred toas “partial” patterns and may be useful in carrying out a “refined” or“detailed” testing of the electrodes 125. For example, a “coarse”pattern such as the electrode activation pattern 140A may be used tocarry out a “coarse” testing, which may reveal that the target nervetissue is covered by the top half of the lead 115A, but it is not knownexactly which electrodes 125 best cover the target nerve tissue.Thereafter, a “refined” testing is performed using the “partial” patternthat includes all the electrodes located in the top half of the lead115A. The “partial” pattern may still divide the electrodes intomultiple subsets, for example three subsets. The “refined” testing stepsthrough each subset of electrodes and consequently will identify whichsubset of electrodes offer the best coverage of the target nerve tissue.

It is understood that the selection of each electrode activation pattern140 may be done by a touch-sensitive user input, for example by a user(e.g., healthcare professional) touching an area of the display on theclinician programmer illustrating the pattern 140. Alternatively, theelectrode pattern menu 130 may further include a virtual togglemechanism 150 that allows the selection of a desired pattern 140 bytoggling among a plurality of available patterns 140. For example, iftwo patterns 140A and 140B exist, and the pattern 140A is currentlyselected, then a “click” of the virtual toggle mechanism 150 changes thecurrent selection of the pattern to 140B, and vice versa. It isunderstood, however, that the virtual toggle mechanism 150 allows themore than just two patterns to be iterated. For example, in someembodiments, the virtual toggle mechanism 150 may be used to togglethrough four or five (or more) patterns iteratively.

The user interface 100 illustrates a virtual control mechanism 160 forcontrolling the activation of the subsets of electrodes 125. In theillustrated embodiment, the virtual control mechanism 160 includes aslider 161 that can be dragged up and down a bar 162. The user (e.g.,healthcare professional) may use his/her finger to engage the virtualcontrol mechanism 160, for example to move the slider 161 to differentpositions on the bar 162. Different positions of the slider 161 on thebar 162 correspond to different subsets of electrodes 125 being selectedon the lead 115A. Therefore, as the user moves the slider 161 along thebar 162, different subsets of electrodes 125 are selected, meaning thatthey are now ready to be activated to begin delivering electricalstimulation to the patient's body.

To initiate the activation of electrodes, the user interface 100 employsa virtual activation mechanism 170. The virtual activation mechanism 170includes a “run” button 171, which if pressed by the user will activatethe selected subset of electrodes 125 (also referred to as electrodesubsets). In other words, the engagement of the “run” button 171 causesthe selected subset of electrodes 125 to begin delivering electricalstimulation to nearby nerve tissue. In the illustrated embodiment, thevirtual activation mechanism 170 further includes a “+” toggle and a “−”toggle, which may be used to adjust the programming value of stimulationparameters such as electrical current, etc.

FIGS. 3A-3D illustrate an example of activating the subsets ofelectrodes using the virtual control mechanism 160. Referring to FIG.3A, the electrode activation pattern 140A is selected from the electrodepattern menu 130 by a user, for example through a touch-sensitive input.The initial position of the virtual control mechanism 160 (i.e., theslider tool) is at the top, which corresponds to the selection of theelectrodes 125A and 125B that are located at the top of the lead 115A.In the illustrated embodiment, the electrodes 125A and 125B areprogrammed with their own stimulation parameters (e.g., current, pulsewidth, frequency, etc.), and one of the electrodes 125A is programmed tobe an anode, and the other one is programmed to be a cathode. The usermay then activate the electrodes 125A and 125B by pressing the “run”button on the virtual activation mechanism 170. The activated electrodes125A and 125B will deliver electrical stimulation to nearby nervetissue.

Referring now to FIG. 3B, the user slides the slider of the virtualcontrol mechanism 160 downward, and consequently the electrodes 125C and125D on the lead 115A become selected. The electrodes 125C and 125D areprogrammed with their own stimulation parameters, which may or may notbe the same as the electrodes 125A and 125B, respectively. Again, theuser may then activate the electrodes 125C and 125D by pressing the“run” button on the virtual activation mechanism 170. The activatedelectrodes 125C and 125D will deliver electrical stimulation to nearbynerve tissue.

Referring now to FIG. 3C, the user slides the slider of the virtualcontrol mechanism 160 further downward, and consequently the electrodes125E and 125F on the lead 115A become selected. The electrodes 125E and125F are programmed with their own stimulation parameters, which may ormay not be the same as the electrodes 125A and 125B or 125C and 125D,respectively. Again, the user may then activate the electrodes 125E and125F by pressing the “run” button on the virtual activation mechanism170. The activated electrodes 125E and 125F will deliver electricalstimulation to nearby nerve tissue.

Referring now to FIG. 3D, the user slides the slider in the virtualcontrol mechanism 160 downward again, and consequently the electrodes125G and 125H on the lead 115A become selected. The electrodes 125G and125H are programmed with their own stimulation parameters, which may ormay not be the same as the electrodes 125A and 125B, 125C and 125D, or125E and 125F, respectively. Again, the user may then activate theelectrodes 125G and 125H by pressing the “run” button on the virtualactivation mechanism 170. The activated electrodes 125G and 125H willdeliver electrical stimulation to nearby nerve tissue.

During the electrode configuration and positioning process describedabove with reference to FIGS. 3A-3D, the patient may provide feedbackverbally or with a patient feedback tool 180, an embodiment of which isillustrated in FIG. 4. The patient feedback tool 180 (also referred toas a patient feedback device) is a portable hand held device and issensitive to pressure. The patient may squeeze the patient feedback tool180 more or less to convey the level of pain reduction they experiencein response to the delivered electrical stimulation. In someembodiments, the patient feedback tool 180 may also be calibrated foreach patient before surgery to take into account of that particularpatient's strength and grip. Additional aspects and other embodiments ofthe patient feedback tool 180 are described in more detail in U.S.Patent Application No. 2012/0310305, filed on May 31, 2011, and entitled“Patient handheld device for use with a spinal cord stimulation system”to Kaula, et al., the disclosure of which is hereby incorporated byreference in its entirety. It is understood, however, that the patientfeedback tool 180 is used herein merely as an example mechanism forproviding and obtaining patient feedback. In other embodiments, othersuitable tools and devices may be used to obtain a pressure-basedfeedback, or different forms of feedback, such as verbal feedback. Afterthe activation of the subsets of electrodes 125 according to the pattern140A, the healthcare professional considers the patient feedback and mayadjust the physical location of the actual implanted lead (representedby the virtual lead 115A). This adjustment is done during the implantsurgery. In addition, the healthcare professional may also tweak thestimulation parameters of one or more of the electrodes 125.

It is understood that, if electrical stimulation is still turned onwhile the virtual control mechanism 160 is being used to changeelectrode positions (i.e., selecting different subsets of electrodes foractivation), the patient may feel discomfort or pain, particularly ifthe different subsets of electrodes are located relatively far away fromone another, and thus moving down the “slider” (i.e., the virtualcontrol mechanism 160) will trigger electrodes to deliver pulses inregions of the body where no pain is felt and no stimulation is needed.Hence, as a safety control feature, the user interface 100 hides thevirtual control mechanism 160 while electrical stimulation is on, asshown in FIG. 5. It is only when electrical stimulation is turned off(such as shown in FIGS. 3A-3D) that the virtual control mechanism 160will become visible again.

FIG. 5 also illustrates another electrode pattern menu (or library) 130Athat includes a plurality of other example electrode activation patterns140C-140H. These electrode activation patterns 140C-140H are definedwith respect to a single column 1×12 implant lead 115B, which containstwelve electrodes. Again, each of the electrode activation patterns140C-140H correspond to different subsets of the electrodes on the lead115B being selectable and activatable, and the electrodes may each havetheir own stimulation parameters. In situations where all of theelectrodes are configured to be anodes (or cathodes), such as in theelectrode activation patterns 140G and 140H, an enclosure 190 (alsoreferred to as a “can”) or grounding wire (not illustrated) may be usedto balance the stimulation current.

It is understood that the part of the user interface 100 used toaccomplish the electrode configuration and positioning process discussedabove is not limited to what is shown in FIGS. 2, 3 and 5. Rather, theuser interface 100 may contain additional features and/or may implementthe features described above differently. For example, though thevirtual control mechanism 160 manifests itself as a “slider tool” in theillustrated embodiments, a virtual joystick, a virtual toggle, or avirtual switch may also be used to implement the virtual controlmechanism. As another example, in some embodiments, a virtual button ortoggle can be implemented in the user interface 100 to reverse thepolarity of all the electrodes, so that all cathodes will become anodes,and all anodes will become cathodes. As a further example, the userinterface 100 may be configured to let the user simply click on theelectrode subsets of interest directly on the lead 115 to select theseelectrode subsets, thereby bypassing the use of the virtual controlmechanism 160. As yet another example, the electrode pattern menu 130may be obviated in some embodiments. Instead, a plurality of leadssimilar to the lead 115A/115B may be displayed side by side (spacepermitting). Each of the displayed lead may have a clear indication ofwhat the activatable subsets of electrodes are. Thus, to select adesired electrode configuration pattern, the healthcare professional (orany other user) simply needs to click on a particular lead among theseveral displayed leads.

The electrode configuration and positioning process discussed above mayalso be performed automatically without using the virtual controlmechanism 160. For example, referring now to FIG. 6, the subsets ofelectrodes 125 in an electrode activation pattern 140 may be selectedand activated automatically with pauses between the activation of eachelectrode subset for patient feedback, which may be provided using thepatient feedback tool 180 or other types of feedback. The user selects alead 115A and an electrode activation pattern 140 to apply to the lead115A, and then an automated pattern stimulation option 195 is selected,as shown in FIG. 6. In this example, the subset of electrodes located inthe top of the lead 115A is activated until the patient squeezes thepatient feedback tool 180 or a timeout has occurred. Thereafter, thepattern is shifted to the next position (i.e., the subset of electrodesbelow the top electrodes are selected and activated). This processrepeats until all the electrode subsets identified by the pattern 140have been covered. The patient may signal depth or lack of stimulation(or different degrees of pain reduction) by applying different amountsof force to the patient feedback tool 180. For example, stimulation notbeing felt can be signaled by no squeeze, any stimulation felt can besignaled by a medium squeeze, and painful stimulation can be signaled bya hard squeeze.

In some embodiments, the user interface 100 may also be able to providea recommendation as to repositioning of the lead 115. For example,referring to FIG. 7, an electrode configuration and positioning processas discussed above has been performed using the electrode activationpattern 140E. Suppose that, of all the electrode subsets tested, thesubset consisting of electrodes 125M and 125N offered the patient thegreatest pain reduction. In terms of providing neurostimulation, one ortwo electrodes may be sufficient to provide the necessary electricalstimulation to the target nerve tissue. Thus, if the lead 115B isimplanted as is in the patient, the electrodes 125M and 125N will beable to offer the patient the desired neurostimulation to reduce thepain.

However, as a practical matter, the position of the lead 115B may shiftafter implantation, which may occur over time as the patient moveshis/her body. Even a small positional shift of the lead may cause thetarget nerve tissue to fall outside the coverage area of the electrodes125M and 125N. Therefore, to ensure effective coverage and to createredundancy, the lead 115B (as well as nearly all other types of leads)includes a plurality of electrodes that span a greater distance, so asto account for the future potential positional shift of the lead 115B.It may be desirable to implant the lead 115B in a manner such that itscenter electrodes (e.g., 125K and 125L) are positionally-aligned withthe target nerve tissue, once the target nerve tissue is identifiedthrough the electrode configuration and positioning process discussedabove.

In the example discussed herein, the target nerve tissue is locatedproximate to the current implant position of the electrodes 125M and125N. Therefore, in order to ensure redundancy, the center electrodes125K and 125L should be repositioned proximate to (or until they arealigned with) such target nerve tissue. In some embodiments, the userinterface 100 may display a text-based recommendation 200 to the user,which may state “MOVE THE LEAD DOWN” to let the user know that the lead115B needs to be repositioned downward along the spine to achieve thedesired redundancy. The recommendation 200 may be even more specific andmay state “MOVE THE LEAD DOWN 3 CENTIMETERS” as an example. Therepositioning distance may be calculated as a function of the length ofthe lead 115B. In embodiments where more than one column of electrodesis used in a lead, the recommendation may also include a recommendedshift to the left or to the right. In some other embodiments, therecommendation may be verbally announced to the user rather than beingdisplayed as text.

In addition to, or instead of displaying the text-based recommendation200 (or verbally announcing the recommendation), the user interface 100may also graphically display a recommended location for the lead. In theembodiment shown in FIG. 7, the recommended location for the lead isillustrated as an outline contour 210 of the lead. The recommendedlocation for the outline contour 210 is calculated in response topatient feedback and the geometries (e.g., length and/or width) of thelead. Since the outline contour 210 is graphically overlaid on top ofparticular segments of the spinal cord (e.g., C1-C7 for the top 7vertebrae of the cervical region, T1-C12 for the next 12 vertebrae ofthe thoracic region, L1-L5 for the final 5 vertebrae of the lumbarregion, and S1-S5 for the 9 fused vertebrae of the sacrococcygealregion), the healthcare profession will know exactly where to repositionthe lead so that the center of the lead is aligned with the target nervetissue.

FIG. 8 is a simplified flowchart of a method 300 of determiningelectrode configuration and positioning for neurostimulation accordingto various aspects of the present disclosure. The method 300 includes astep 310 to initiate the determination of electrode pattern and leadposition. The method 300 continues to a step 315, in which a presetelectrode pattern is selected. The method 300 continues to a step 320,in which a lead is positioned. The method 300 continues to a step 325,in which the automated pattern stimulation is turned on. The method 300continues to a step 330, in which the pattern is automatically shifteddown a position. The method 300 continues to a decision step 335 todetermine whether the patient's pain area is covered. If the answer tothe decision step 335 is yes, the method 300 proceeds to anotherdecision step 340 to determine whether it is the center electrodes onthe lead. If the answer is yes, then the method 300 continues to a step345 where the lead is marked a success. If the answer from the decisionstep 340 is no, then the method 300 proceeds to another decision step360 (discussed below).

If the answer from the decision step 335 is no (or if the answer fromthe decision step 340 is no), then the method 300 continues to adecision step 360 to determine whether the last set of electrodes on thelead has been reached. If the answer from the decision step 360 is no,the method 300 proceeds to step 330. If the answer from the decisionstep 360 is yes, then the method 300 proceeds to another decision step365 to determine whether the lead has been marked a success. If theanswer from the decision step 365 is no, then the method 300 proceeds toa step 370 to turn stimulation off and thereafter proceeds to the step320. If the answer from the decision step 365 is yes, then the method300 continues to a step 375 to turn stimulation off. The method 300concludes at step 380.

FIG. 9 is a simplified flowchart of a method 500 of determiningelectrode configuration and positioning for neurostimulation accordingto various aspects of the present disclosure. The method 500 includes astep 505, in which a virtual representation of an implant lead isprovided. The implant lead is configured to deliver electricalstimulation to a patient via one or more of a plurality of electrodeslocated on the implant lead.

The method 500 includes a step 510, in which a predefined electrodeactivation pattern is provided. The electrode activation patternidentifies a plurality of subsets of the electrodes that can beactivated one subset at a time. The electrodes in each subset areprogrammed with their respective electrical stimulation parameters. Insome embodiments, the electrical stimulation parameters include at leastone of: current amplitude, pulse width, frequency, or electrodepolarity. In some embodiments, the step 510 is performed such that thedifferent subsets of electrodes are segregated by virtual dividers onthe virtual representation of the implant lead. In some embodiments, theelectrode activation pattern is provided as a part of a pattern librarycontaining a plurality of different predefined electrode activationpatterns.

In some embodiments, the steps 505 and 510 include simultaneouslydisplaying the virtual representation of the implant lead and thepredefined electrode activation pattern on a screen of a clinicianprogrammer. The method 500 may also include a step of displaying, on thescreen of the clinician programmer, a virtual representation of ananatomical environment containing a portion of the spine of the patientand a disposition of the implant lead with respect to the portion of thespine.

The method 500 includes a step 515, in which the subsets of theelectrodes are activated one subset at a time. Each activated subset ofelectrodes delivers electrical stimulation to a different region of aspine of the patient. In some embodiments, the step 515 is performedduring a surgery that implants the implant lead into the patient. Insome embodiments, the step 515 includes automatically activating thesubsets of the electrodes according to a plurality of predefinedsequence steps. A different subset of electrodes is activated at eachsequence step. In some embodiments, the subsets of electrodes areactivated consecutively along a direction.

The method 500 includes a step 520, in which patient feedback isreceived for the activating of each subset of electrodes. The patientfeedback may be received via an electronic patient feedback tool or byverbal communication.

The method 500 includes a step 525, in which a locational adjustment ofthe implant lead is recommended in response to steps 515 and 520. Insome embodiments, the step 525 includes: identifying, based on thepatient feedback, a region of the spine that offers the most painreduction for the patient; and recommending the locational adjustment ofthe implant lead in a manner such that one or more electrodes locatednear a center of the implant lead are aligned with the region of thespine that offers the most pain reduction for the patient.

It is understood that additional process steps may be performed before,during, or after the steps 505-525. For example, the method 500 mayfurther include a step of displaying a virtual control mechanism and astep of detecting, from a user, an engagement of the virtual controlmechanism. The activating the subsets of electrodes may be performed inresponse to the detected engagement of the virtual control mechanism. Insome embodiments, the virtual control mechanism includes one of: avirtual slider, a virtual toggle, or a virtual joystick.

FIG. 10 shows a block diagram of one embodiment of the electronicprogrammer (CP) discussed herein. For example, the electronic programmermay be a clinician programmer (CP) configured to determine the electrodeconfiguration and positioning discussed above. It is understood,however, that alternative embodiments of the electronic programmer maybe used to perform these representations as well.

The CP includes a printed circuit board (“PCB”) that is populated with aplurality of electrical and electronic components that provide power,operational control, and protection to the CP. With reference to FIG.10, the CP includes a processor 600. The processor 600 controls the CP.In one construction, the processor 600 is an applications processormodel i.MX515 available from Free scale Semiconductor®. Morespecifically, the i.MX515 applications processor has internalinstruction and data caches, multimedia capabilities, external memoryinterfacing, and interfacing flexibility. Further information regardingthe i.MX515 applications processor can be found in, for example, the“IMX510EC, Rev. 4” data sheet dated August 2010 and published by Freescale Semiconductor® at www.freescale.com. The content of the data sheetis incorporated herein by reference. Of course, other processing units,such as other microprocessors, microcontrollers, digital signalprocessors, etc., can be used in place of the processor 600.

The CP includes memory, which can be internal to the processor 600(e.g., memory 605), external to the processor 600 (e.g., memory 610), ora combination of both. Exemplary memory include a read-only memory(“ROM”), a random access memory (“RAM”), an electrically erasableprogrammable read-only memory (“EEPROM”), a flash memory, a hard disk,or another suitable magnetic, optical, physical, or electronic memorydevice. The processor 600 executes software that is capable of beingstored in the RAM (e.g., during execution), the ROM (e.g., on agenerally permanent basis), or another non-transitory computer readablemedium such as another memory or a disc. The CP also includesinput/output (“I/O”) systems that include routines for transferringinformation between components within the processor 600 and othercomponents of the CP or external to the CP.

Software included in the implementation of the CP is stored in thememory 605 of the processor 600, RAM 610, ROM 615, or external to theCP. The software includes, for example, firmware, one or moreapplications, program data, one or more program modules, and otherexecutable instructions. The processor 600 is configured to retrievefrom memory and execute, among other things, instructions related to thecontrol processes and methods described below for the CP.

One memory shown in FIG. 10 is memory 610, which may be a double datarate (DDR2) synchronous dynamic random access memory (SDRAM) for storingdata relating to and captured during the operation of the CP. Inaddition, a secure digital (SD) multimedia card (MMC) may be coupled tothe CP for transferring data from the CP to the memory card via slot615. Of course, other types of data storage devices may be used in placeof the data storage devices shown in FIG. 10.

The CP includes multiple bi-directional radio communicationcapabilities. Specific wireless portions included with the CP are aMedical Implant Communication Service (MICS) bi-directional radiocommunication portion 620, a Wi-Fi bi-directional radio communicationportion 625, and a Bluetooth bi-directional radio communication portion630. The MICS portion 620 includes a MICS communication interface, anantenna switch, and a related antenna, all of which allows wirelesscommunication using the MICS specification. The Wi-Fi portion 625 andBluetooth portion 630 include a Wi-Fi communication interface, aBluetooth communication interface, an antenna switch, and a relatedantenna all of which allows wireless communication following the Wi-FiAlliance standard and Bluetooth Special Interest Group standard. Ofcourse, other wireless local area network (WLAN) standards and wirelesspersonal area networks (WPAN) standards can be used with the CP.

The CP includes three hard buttons: a “home” button 635 for returningthe CP to a home screen for the device, a “quick off” button 640 forquickly deactivating stimulation IPG, and a “reset” button 645 forrebooting the CP. The CP also includes an “ON/OFF” switch 650, which ispart of the power generation and management block (discussed below).

The CP includes multiple communication portions for wired communication.Exemplary circuitry and ports for receiving a wired connector include aportion and related port for supporting universal serial bus (USB)connectivity 655, including a Type A port and a Micro-B port; a portionand related port for supporting Joint Test Action Group (JTAG)connectivity 660, and a portion and related port for supportinguniversal asynchronous receiver/transmitter (UART) connectivity 665. Ofcourse, other wired communication standards and connectivity can be usedwith or in place of the types shown in FIG. 10.

Another device connectable to the CP, and therefore supported by the CP,is an external display. The connection to the external display can bemade via a micro High-Definition Multimedia Interface (HDMI) 670, whichprovides a compact audio/video interface for transmitting uncompresseddigital data to the external display. The use of the HDMI connection 670allows the CP to transmit video (and audio) communication to an externaldisplay. This may be beneficial in situations where others (e.g., thesurgeon) may want to view the information being viewed by the healthcareprofessional. The surgeon typically has no visual access to the CP inthe operating room unless an external screen is provided. The HDMIconnection 670 allows the surgeon to view information from the CP,thereby allowing greater communication between the clinician and thesurgeon. For a specific example, the HDMI connection 670 can broadcast ahigh definition television signal that allows the surgeon to view thesame information that is shown on the LCD (discussed below) of the CP.

The CP includes a touch screen I/O device 675 for providing a userinterface with the clinician. The touch screen display 675 can be aliquid crystal display (LCD) having a resistive, capacitive, or similartouch-screen technology. It is envisioned that multitouch capabilitiescan be used with the touch screen display 675 depending on the type oftechnology used.

The CP includes a camera 680 allowing the device to take pictures orvideo. The resulting image files can be used to document a procedure oran aspect of the procedure. Other devices can be coupled to the CP toprovide further information, such as scanners or RFID detection.Similarly, the CP includes an audio portion 685 having an audio codeccircuit, audio power amplifier, and related speaker for providing audiocommunication to the user, such as the clinician or the surgeon.

The CP further includes a power generation and management block 690. Thepower block 690 has a power source (e.g., a lithium-ion battery) and apower supply for providing multiple power voltages to the processor, LCDtouch screen, and peripherals.

In one embodiment, the CP is a handheld computing tablet with touchscreen capabilities. The tablet is a portable personal computer with atouch screen, which is typically the primary input device. However, anexternal keyboard or mouse can be attached to the CP. The tablet allowsfor mobile functionality not associated with even typical laptoppersonal computers. The hardware may include a Graphical Processing Unit(GPU) in order to speed up the user experience. An Ethernet port (notshown in FIG. 10) may also be included for data transfer.

It is understood that a patient programmer may be implemented in asimilar manner as the clinician programmer shown in FIG. 10.

FIG. 11 shows a block diagram of one embodiment of an implantablemedical device. In the embodiment shown in FIG. 11, the implantablemedical device includes an implantable pulse generator (IPG). The IPGincludes a printed circuit board (“PCB”) that is populated with aplurality of electrical and electronic components that provide power,operational control, and protection to the IPG. With reference to FIG.11, the IPG includes a communication portion 700 having a transceiver705, a matching network 710, and antenna 712. The communication portion700 receives power from a power ASIC (discussed below), and communicatesinformation to/from the microcontroller 715 and a device (e.g., the CP)external to the IPG. For example, the IPG can provide bi-direction radiocommunication capabilities, including Medical Implant CommunicationService (MICS) bi-direction radio communication following the MICSspecification.

The IPG provides stimuli to electrodes of an implanted medicalelectrical lead (not illustrated herein). As shown in FIG. 11, Nelectrodes are connected to the IPG. In addition, the enclosure orhousing 720 of the IPG can act as an electrode. The stimuli are providedby a stimulation portion 225 in response to commands from themicrocontroller 215. The stimulation portion 725 includes a stimulationapplication specific integrated circuit (ASIC) 730 and circuitryincluding blocking capacitors and an over-voltage protection circuit. Asis well known, an ASIC is an integrated circuit customized for aparticular use, rather than for general purpose use. ASICs often includeprocessors, memory blocks including ROM, RAM, EEPROM, FLASH, etc. Thestimulation ASIC 730 can include a processor, memory, and firmware forstoring preset pulses and protocols that can be selected via themicrocontroller 715. The providing of the pulses to the electrodes iscontrolled through the use of a waveform generator and amplitudemultiplier of the stimulation ASIC 730, and the blocking capacitors andovervoltage protection circuitry 735 of the stimulation portion 725, asis known in the art. The stimulation portion 725 of the IPG receivespower from the power ASIC (discussed below). The stimulation ASIC 730also provides signals to the microcontroller 715. More specifically, thestimulation ASIC 730 can provide impedance values for the channelsassociated with the electrodes, and also communicate calibrationinformation with the microcontroller 715 during calibration of the IPG.

The IPG also includes a power supply portion 740. The power supplyportion includes a rechargeable battery 745, fuse 750, power ASIC 755,recharge coil 760, rectifier 763 and data modulation circuit 765. Therechargeable battery 745 provides a power source for the power supplyportion 740. The recharge coil 760 receives a wireless signal from thePPC. The wireless signal includes an energy that is converted andconditioned to a power signal by the rectifier 763. The power signal isprovided to the rechargeable battery 745 via the power ASIC 755. Thepower ASIC 755 manages the power for the IPG. The power ASIC 755provides one or more voltages to the other electrical and electroniccircuits of the IPG. The data modulation circuit 765 controls thecharging process.

The IPG also includes a magnetic sensor 780. The magnetic sensor 780provides a “hard” switch upon sensing a magnet for a defined period. Thesignal from the magnetic sensor 780 can provide an override for the IPGif a fault is occurring with the IPG and is not responding to othercontrollers.

The IPG is shown in FIG. 11 as having a microcontroller 715. Generallyspeaking, the microcontroller 715 is a controller for controlling theIPG. The microcontroller 715 includes a suitable programmable portion785 (e.g., a microprocessor or a digital signal processor), a memory790, and a bus or other communication lines. An exemplarymicrocontroller capable of being used with the IPG is a model MSP430ultra-low power, mixed signal processor by Texas Instruments. Morespecifically, the MSP430 mixed signal processor has internal RAM andflash memories, an internal clock, and peripheral interfacecapabilities. Further information regarding the MSP 430 mixed signalprocessor can be found in, for example, the “MSP430G2×32, MSP430G2×02MIXED SIGNAL MICROCONTROLLER” data sheet; dated December 2010, publishedby Texas Instruments at www.ti.com; the content of the data sheet beingincorporated herein by reference.

The IPG includes memory, which can be internal to the control device(such as memory 790), external to the control device (such as serialmemory 795), or a combination of both. Exemplary memory include aread-only memory (“ROM”), a random access memory (“RAM”), anelectrically erasable programmable read-only memory (“EEPROM”), a flashmemory, a hard disk, or another suitable magnetic, optical, physical, orelectronic memory device. The programmable portion 785 executes softwarethat is capable of being stored in the RAM (e.g., during execution), theROM (e.g., on a generally permanent basis), or another non-transitorycomputer readable medium such as another memory or a disc.

Software included in the implementation of the IPG is stored in thememory 790. The software includes, for example, firmware, one or moreapplications, program data, one or more program modules, and otherexecutable instructions. The programmable portion 785 is configured toretrieve from memory and execute, among other things, instructionsrelated to the control processes and methods described below for theIPG. For example, the programmable portion 285 is configured to executeinstructions retrieved from the memory 790 for sweeping the electrodesin response to a signal from the CP.

Referring now to FIG. 12, a simplified block diagram of a medicalinfrastructure 800 (which may also be considered a medical system) isillustrated according to various aspects of the present disclosure. Themedical infrastructure 800 includes a plurality of medical devices 810.These medical devices 810 may each be a programmable medical device (orparts thereof) that can deliver a medical therapy to a patient. In someembodiments, the medical devices 810 may include a device of theneurostimulator system discussed above with reference to FIG. 1. Forexample, the medical devices 810 may be a pulse generator (e.g., the IPGdiscussed above with reference to FIG. 11), an implantable lead, acharger, or portions thereof. It is understood that each of the medicaldevices 810 may be a different type of medical device. In other words,the medical devices 810 need not be the same type of medical device.

The medical infrastructure 800 also includes a plurality of electronicprogrammers 820. For sake of illustration, one of these electronicprogrammers 820A is illustrated in more detail and discussed in detailbelow. Nevertheless, it is understood that each of the electronicprogrammers 820 may be implemented similar to the electronic programmer820A.

In some embodiments, the electronic programmer 820A may be a clinicianprogrammer, for example the clinician programmer discussed above withreference to FIG. 10. In other embodiments, the electronic programmer820A may be a patient programmer or another similar programmer. Infurther embodiments, it is understood that the electronic programmer maybe a tablet computer. In any case, the electronic programmer 820A isconfigured to program the stimulation parameters of the medical devices810 so that a desired medical therapy can be delivered to a patient.

The electronic programmer 820A contains a communications component 830that is configured to conduct electronic communications with externaldevices. For example, the communications device 830 may include atransceiver. The transceiver contains various electronic circuitrycomponents configured to conduct telecommunications with one or moreexternal devices. The electronic circuitry components allow thetransceiver to conduct telecommunications in one or more of the wired orwireless telecommunications protocols, including communicationsprotocols such as IEEE 802.11 (Wi-Fi), IEEE 802.15 (Bluetooth), GSM,CDMA, LTE, WIMAX, DLNA, HDMI, Medical Implant Communication Service(MICS), etc. In some embodiments, the transceiver includes antennas,filters, switches, various kinds of amplifiers such as low-noiseamplifiers or power amplifiers, digital-to-analog (DAC) converters,analog-to-digital (ADC) converters, mixers, multiplexers anddemultiplexers, oscillators, and/or phase-locked loops (PLLs). Some ofthese electronic circuitry components may be integrated into a singlediscrete device or an integrated circuit (IC) chip.

The electronic programmer 820A contains a touchscreen component 840. Thetouchscreen component 840 may display a touch-sensitive graphical userinterface that is responsive to gesture-based user interactions. Thetouch-sensitive graphical user interface may detect a touch or amovement of a user's finger(s) on the touchscreen and interpret theseuser actions accordingly to perform appropriate tasks. The graphicaluser interface may also utilize a virtual keyboard to receive userinput. In some embodiments, the touch-sensitive screen may be acapacitive touchscreen. In other embodiments, the touch-sensitive screenmay be a resistive touchscreen.

It is understood that the electronic programmer 820A may optionallyinclude additional user input/output components that work in conjunctionwith the touchscreen component 840 to carry out communications with auser. For example, these additional user input/output components mayinclude physical and/or virtual buttons (such as power and volumebuttons) on or off the touch-sensitive screen, physical and/or virtualkeyboards, mouse, track balls, speakers, microphones, light-sensors,light-emitting diodes (LEDs), communications ports (such as USB or HDMIports), joy-sticks, etc.

The electronic programmer 820A contains an imaging component 850. Theimaging component 850 is configured to capture an image of a targetdevice via a scan. For example, the imaging component 850 may be acamera in some embodiments. The camera may be integrated into theelectronic programmer 820A. The camera can be used to take a picture ofa medical device, or scan a visual code of the medical device, forexample its barcode or Quick Response (QR) code.

The electronic programmer contains a memory storage component 860. Thememory storage component 860 may include system memory, (e.g., RAM),static storage 608 (e.g., ROM), or a disk drive (e.g., magnetic oroptical), or any other suitable types of computer readable storagemedia. For example, some common types of computer readable media mayinclude floppy disk, flexible disk, hard disk, magnetic tape, any othermagnetic medium, CD-ROM, any other optical medium, RAM, PROM, EPROM,FLASH-EPROM, any other memory chip or cartridge, or any other mediumfrom which a computer is adapted to read. The computer readable mediummay include, but is not limited to, non-volatile media and volatilemedia. The computer readable medium is tangible, concrete, andnon-transitory. Logic (for example in the form of computer software codeor computer instructions) may be encoded in such computer readablemedium. In some embodiments, the memory storage component 860 (or aportion thereof) may be configured as a local database capable ofstoring electronic records of medical devices and/or their associatedpatients.

The electronic programmer contains a processor component 870. Theprocessor component 870 may include a central processing unit (CPU), agraphics processing unit (GPU) a micro-controller, a digital signalprocessor (DSP), or another suitable electronic processor capable ofhandling and executing instructions. In various embodiments, theprocessor component 870 may be implemented using various digital circuitblocks (including logic gates such as AND, OR, NAND, NOR, XOR gates,etc.) along with certain software code. In some embodiments, theprocessor component 870 may execute one or more sequences computerinstructions contained in the memory storage component 860 to performcertain tasks.

It is understood that hard-wired circuitry may be used in place of (orin combination with) software instructions to implement various aspectsof the present disclosure. Where applicable, various embodimentsprovided by the present disclosure may be implemented using hardware,software, or combinations of hardware and software. Also, whereapplicable, the various hardware components and/or software componentsset forth herein may be combined into composite components comprisingsoftware, hardware, and/or both without departing from the spirit of thepresent disclosure. Where applicable, the various hardware componentsand/or software components set forth herein may be separated intosub-components comprising software, hardware, or both without departingfrom the scope of the present disclosure. In addition, where applicable,it is contemplated that software components may be implemented ashardware components and vice-versa.

It is also understood that the electronic programmer 820A is notnecessarily limited to the components 830-870 discussed above, but itmay further include additional components that are used to carry out theprogramming tasks. These additional components are not discussed hereinfor reasons of simplicity. It is also understood that the medicalinfrastructure 800 may include a plurality of electronic programmerssimilar to the electronic programmer 820A discussed herein, but they arenot illustrated in FIG. 12 for reasons of simplicity.

The medical infrastructure 800 also includes an institutional computersystem 890. The institutional computer system 890 is coupled to theelectronic programmer 820A. In some embodiments, the institutionalcomputer system 890 is a computer system of a healthcare institution,for example a hospital. The institutional computer system 890 mayinclude one or more computer servers and/or client terminals that mayeach include the necessary computer hardware and software for conductingelectronic communications and performing programmed tasks. In variousembodiments, the institutional computer system 890 may includecommunications devices (e.g., transceivers), user input/output devices,memory storage devices, and computer processor devices that may sharesimilar properties with the various components 830-870 of the electronicprogrammer 820A discussed above. For example, the institutional computersystem 890 may include computer servers that are capable ofelectronically communicating with the electronic programmer 820A throughthe MICS protocol or another suitable networking protocol.

The medical infrastructure 800 includes a database 900. In variousembodiments, the database 900 is a remote database—that is, locatedremotely to the institutional computer system 890 and/or the electronicprogrammer 820A. The database 900 is electronically or communicatively(for example through the Internet) coupled to the institutional computersystem 890 and/or the electronic programmer. In some embodiments, thedatabase 900, the institutional computer system 890, and the electronicprogrammer 820A are parts of a cloud-based architecture. In that regard,the database 900 may include cloud-based resources such as mass storagecomputer servers with adequate memory resources to handle requests froma variety of clients. The institutional computer system 890 and theelectronic programmer 820A (or their respective users) may both beconsidered clients of the database 900. In certain embodiments, thefunctionality between the cloud-based resources and its clients may bedivided up in any appropriate manner. For example, the electronicprogrammer 820A may perform basic input/output interactions with a user,but a majority of the processing and caching may be performed by thecloud-based resources in the database 900. However, other divisions ofresponsibility are also possible in various embodiments.

According to the various aspects of the present disclosure, electronicdata, such as pain and stimulation maps (collectively referred to assensation maps) may be uploaded from the electronic programmer 820A tothe database 900. The sensation maps are discussed in more detail inprovisional U.S. Patent Application No. 61/695,407, filed on Aug. 31,2012, entitled “Method and System of Producing 2D Representations of 3DPain and Stimulation Maps and Implant Models on a Clinician Programmer,”and provisional U.S. Patent Application No. 61/695,721, filed on Aug.31, 2012, entitled “Method and System of Creating, Displaying, andComparing Pain and Stimulation Maps,” and provisional U.S. PatentApplication No. 61/695,676, filed on Aug. 31, 2012, entitled “Method andSystem of Adjusting 3D Models of Patients on a Clinician Programmer,”the disclosure of each of which is hereby incorporated by reference inits entirety.

The sensation maps saved in the database 900 may thereafter bedownloaded by any of the other electronic programmers 820B-820Ncommunicatively coupled to it, assuming the user of these programmershas the right login permissions. For example, after the 2D sensation mapis generated by the electronic programmer 820A and uploaded to thedatabase 900. That 2D sensation map can then be downloaded by theelectronic programmer 820B, which can use the downloaded 2D sensationmap to reconstruct or recreate a 3D sensation map. In this manner, aless data-intensive 2D sensation map may be derived from a data-heavy 3Dsensation map, sent to a different programmer through the database, andthen be used to reconstruct the 3D sensation map. The sensation maps areused herein merely as an example to illustrate the transfer ofelectronic data in the medical infrastructure 800. Other types ofelectronic data may also be transferred in a similar (or different)manner.

The database 900 may also include a manufacturer's database in someembodiments. It may be configured to manage an electronic medical deviceinventory, monitor manufacturing of medical devices, control shipping ofmedical devices, and communicate with existing or potential buyers (suchas a healthcare institution). For example, communication with the buyermay include buying and usage history of medical devices and creation ofpurchase orders. A message can be automatically generated when a client(for example a hospital) is projected to run out of equipment, based onthe medical device usage trend analysis done by the database. Accordingto various aspects of the present disclosure, the database 900 is ableto provide these functionalities at least in part via communication withthe electronic programmer 820A and in response to the data sent by theelectronic programmer 820A. These functionalities of the database 900and its communications with the electronic programmer 820A will bediscussed in greater detail later.

The medical infrastructure 800 further includes a manufacturer computersystem 910. The manufacturer computer system 910 is also electronicallyor communicatively (for example through the Internet) coupled to thedatabase 900. Hence, the manufacturer computer system 910 may also beconsidered a part of the cloud architecture. The computer system 910 isa computer system of medical device manufacturer, for example amanufacturer of the medical devices 810 and/or the electronic programmer820A.

In various embodiments, the manufacturer computer system 910 may includeone or more computer servers and/or client terminals that each includesthe necessary computer hardware and software for conducting electroniccommunications and performing programmed tasks. In various embodiments,the manufacturer computer system 910 may include communications devices(e.g., transceivers), user input/output devices, memory storage devices,and computer processor devices that may share similar properties withthe various components 830-870 of the electronic programmer 820Adiscussed above. Since both the manufacturer computer system 910 and theelectronic programmer 820A are coupled to the database 900, themanufacturer computer system 910 and the electronic programmer 820A canconduct electronic communication with each other.

FIG. 13A is a side view of a spine 1000, and FIG. 13B is a posteriorview of the spine 1000. The spine 1000 includes a cervical region 1010,a thoracic region 1020, a lumbar region 1030, and a sacrococcygealregion 1040. The cervical region 1010 includes the top 7 vertebrae,which may be designated with C1-C7. The thoracic region 1020 includesthe next 12 vertebrae below the cervical region 1010, which may bedesignated with T1-T12. The lumbar region 1030 includes the final 5“true” vertebrae, which may be designated with L1-L5. The sacrococcygealregion 1040 includes 9 fused vertebrae that make up the sacrum and thecoccyx. The fused vertebrae of the sacrum may be designated with S1-S5.

Neural tissue (not illustrated for the sake of simplicity) branch offfrom the spinal cord through spaces between the vertebrae. The neuraltissue can be individually and selectively stimulated in accordance withvarious aspects of the present disclosure. For example, referring toFIG. 13B, an IPG device 1100 is implanted inside the body. The IPGdevice 1100 may include a neurostimulator device. A conductive lead 1110is electrically coupled to the circuitry inside the IPG device 1100. Theconductive lead 1110 may be removably coupled to the IPG device 1100through a connector, for example. A distal end of the conductive lead1110 is attached to one or more electrodes 1120. The electrodes 1120 areimplanted adjacent to a desired nerve tissue in the thoracic region1020. Using well-established and known techniques in the art, the distalend of the lead 1110 with its accompanying electrodes may be positionedalong or near the epidural space of the spinal cord. It is understoodthat although only one conductive lead 1110 is shown herein for the sakeof simplicity, more than one conductive lead 1110 and correspondingelectrodes 1120 may be implanted and connected to the IPG device 1100.

The electrodes 1120 deliver current drawn from the current sources inthe IPG device 1100, therefore generating an electric field near theneural tissue. The electric field stimulates the neural tissue toaccomplish its intended functions. For example, the neural stimulationmay alleviate pain in an embodiment. In other embodiments, a stimulatormay be placed in different locations throughout the body and may beprogrammed to address a variety of problems, including for example butwithout limitation; prevention or reduction of epileptic seizures,weight control or regulation of heart beats.

It is understood that the IPG device 1100, the lead 1110, and theelectrodes 1120 may be implanted completely inside the body, may bepositioned completely outside the body or may have only one or morecomponents implanted within the body while other components remainoutside the body. When they are implanted inside the body, the implantlocation may be adjusted (e.g., anywhere along the spine 1000) todeliver the intended therapeutic effects of spinal cord electricalstimulation in a desired region of the spine. Furthermore, it isunderstood that the IPG device 1100 may be controlled by a patientprogrammer or a clinician programmer 1200, the implementation of whichmay be similar to the clinician programmer shown in FIG. 10.

The foregoing has outlined features of several embodiments so that thoseskilled in the art may better understand the detailed description thatfollows. Those skilled in the art should appreciate that they mayreadily use the present disclosure as a basis for designing or modifyingother processes and structures for carrying out the same purposes and/orachieving the same advantages of the embodiments introduced herein.Those skilled in the art should also realize that such equivalentconstructions do not depart from the spirit and scope of the presentdisclosure, and that they may make various changes, substitutions andalterations herein without departing from the spirit and scope of thepresent disclosure.

What is claimed is:
 1. An electronic device for determining electrodeconfiguration and positioning for neurostimulation, the electronicdevice comprising: a memory storage component configured to storeprogramming instructions; and a computer processor configured to executethe programming instructions to perform the following operations:providing, via a graphical user interface, a model of an implantablelead, the implantable lead being configured to deliver electricalstimulation to a patient via a plurality of electrodes located on theimplantable lead; providing, via the graphical user interface, aplurality of predefined electrode activation patterns that include acoarse pattern and a refined pattern, the coarse pattern correspondingto a first group of electrodes that are located in a first region of theimplantable lead, the refined pattern corresponding to a second group ofelectrodes that are located in a second region of the implantable lead,wherein the second region is smaller than, and is a subsection of, thefirst region; performing a coarse testing process by selectivelyactivating the first group of electrodes belonging to the coarsepattern; and thereafter performing a refined testing process byselectively activating the second group of electrodes belonging to therefined pattern.
 2. The electronic device of claim 1, wherein: theproviding of the plurality of predefined electrode activation patternscomprises: displaying, via the graphical user interface, a virtuallibrary that contains the plurality of predefined electrode activationpatterns; the performing of the coarse testing process comprises:selecting the coarse pattern from the virtual library; and theperforming of the refined testing process comprises: selecting therefined pattern from the virtual library.
 3. The electronic device ofclaim 1, wherein the operations further comprise: defining, in responseto a first user input, a first electrode activation pattern; saving, inthe memory storage component or in a remote server, the first electrodeactivation pattern as the coarse pattern; defining, in response to asecond user input, a second electrode activation pattern; and saving, inthe memory storage component or in the remote server, the secondelectrode activation pattern as the refined pattern.
 4. The electronicdevice of claim 1, wherein: according to the coarse pattern, the firstgroup of electrodes is divided into a first plurality of subsets ofelectrodes that can be independently activated one subset at a time;according to the refined pattern, the second group of electrodes isdivided into a second plurality of subsets of electrodes that can beindependently activated one subset at a time, the second plurality ofsubsets being different from the first plurality of subsets; and eachsubset of electrodes in the first group or the second group arepreprogrammed with their respective electrical stimulation programmingparameters.
 5. The electronic device of claim 4, wherein the operationsfurther comprise: as each subset of the electrodes is activated,highlighting said activated subset of the electrodes on the model of theimplantable lead in the graphical user interface.
 6. The electronicdevice of claim 1, wherein the operations further comprise: displaying,via the graphical user interface, a virtual control mechanism configuredto be engaged by a user, wherein the selectively activating of the firstgroup of electrodes or the selectively activating of the second group ofelectrodes is performed in response to an engagement of the virtualcontrol mechanism by the user.
 7. The electronic device of claim 1,wherein the operations further comprise: before the refined testingprocess is performed: determining, based on the coarse testing process,that electrodes located in the second region offer better therapeuticrelief for the patient than electrodes located outside the secondregion, wherein the refined testing process is performed in response tothe determining; and identifying, based on the refined testing process,one or more electrodes in the second region that offer a besttherapeutic relief for the patient.
 8. A medical system, comprising: animplantable lead configured to deliver electrical stimulation to apatient via one or more of a plurality of electrodes located on theimplantable lead; and a portable electronic programmer on which agraphical user interface is implemented, wherein the portable electronicprogrammer is configured to perform the following operations: providing,via the graphical user interface, a model of the implantable lead;providing, via the graphical user interface, a plurality of predefinedelectrode activation patterns that include a coarse pattern and arefined pattern, the coarse pattern corresponding to a first group ofelectrodes that are located in a first region of the implantable lead,the refined pattern corresponding to a second group of electrodes thatare located in a second region of the implantable lead, wherein thesecond region is smaller than, and is a subsection of, the first region;performing a coarse testing process by selectively activating the firstgroup of electrodes belonging to the coarse pattern; and thereafterperforming a refined testing process by selectively activating thesecond group of electrodes belonging to the refined pattern.
 9. Themedical system of claim 8, wherein: the providing of the plurality ofpredefined electrode activation patterns comprises: displaying, via thegraphical user interface, a virtual library that contains the pluralityof predefined electrode activation patterns; the performing of thecoarse testing process comprises: selecting the coarse pattern from thevirtual library; and the performing of the refined testing processcomprises: selecting the refined pattern from the virtual library. 10.The medical system of claim 8, wherein the operations further comprise:defining, in response to a first user input, a first electrodeactivation pattern; saving, in the memory storage component or in aremote server, the first electrode activation pattern as the coarsepattern; defining, in response to a second user input, a secondelectrode activation pattern; and saving, in the memory storagecomponent or in the remote server, the second electrode activationpattern as the refined pattern.
 11. The medical system of claim 8,wherein: according to the coarse pattern, the first group of electrodesis divided into a first plurality of subsets of electrodes that can beindependently activated one subset at a time; according to the refinedpattern, the second group of electrodes is divided into a secondplurality of subsets of electrodes that can be independently activatedone subset at a time, the second plurality of subsets being differentfrom the first plurality of subsets; and each subset of electrodes inthe first group or the second group are preprogrammed with theirrespective electrical stimulation programming parameters.
 12. Themedical system of claim 11, wherein the operations further comprise: aseach subset of the electrodes is activated, highlighting said activatedsubset of the electrodes on the model of the implantable lead in thegraphical user interface.
 13. The medical system of claim 8, wherein theoperations further comprise: displaying, via the graphical userinterface, a virtual control mechanism configured to be engaged by auser, wherein the selectively activating of the first group ofelectrodes or the selectively activating of the second group ofelectrodes is performed in response to an engagement of the virtualcontrol mechanism by the user.
 14. The medical system of claim 8,wherein the operations further comprise: before the refined testingprocess is performed: determining, based on the coarse testing process,that electrodes located in the second region offer better therapeuticrelief for the patient than electrodes located outside the secondregion, wherein the refined testing process is performed in response tothe determining; and identifying, based on the refined testing process,one or more electrodes in the second region that offer a besttherapeutic relief for the patient.
 15. A method of determiningelectrode configuration and positioning for neurostimulation, the methodcomprising: providing, via a graphical user interface, a model of animplantable lead, the implantable lead being configured to deliverelectrical stimulation to a patient via a plurality of electrodeslocated on the implantable lead; providing, via the graphical userinterface, a plurality of predefined electrode activation patterns thatinclude a coarse pattern and a refined pattern, the coarse patterncorresponding to a first group of electrodes that are located in a firstregion of the implantable lead, the refined pattern corresponding to asecond group of electrodes that are located in a second region of theimplantable lead, wherein the second region is smaller than, and is asubsection of, the first region; performing a coarse testing process byselectively activating the first group of electrodes belonging to thecoarse pattern; and thereafter performing a refined testing process byselectively activating the second group of electrodes belonging to therefined pattern.
 16. The method of claim 15, wherein: the providing ofthe plurality of predefined electrode activation patterns comprises:displaying, via the graphical user interface, a virtual library thatcontains the plurality of predefined electrode activation patterns; theperforming of the coarse testing process comprises: selecting the coarsepattern from the virtual library; and the performing of the refinedtesting process comprises: selecting the refined pattern from thevirtual library.
 17. The method of claim 15, further comprising:defining, in response to a first user input, a first electrodeactivation pattern; saving, in the memory storage component or in aremote server, the first electrode activation pattern as the coarsepattern; defining, in response to a second user input, a secondelectrode activation pattern; and saving, in the memory storagecomponent or in the remote server, the second electrode activationpattern as the refined pattern.
 18. The method of claim 15, wherein:according to the coarse pattern, the first group of electrodes isdivided into a first plurality of subsets of electrodes that can beindependently activated one subset at a time; according to the refinedpattern, the second group of electrodes is divided into a secondplurality of subsets of electrodes that can be independently activatedone subset at a time, the second plurality of subsets being differentfrom the first plurality of subsets; and each subset of electrodes inthe first group or the second group are preprogrammed with theirrespective electrical stimulation programming parameters; and whereinthe method further comprises: as each subset of the electrodes isactivated, highlighting said activated subset of the electrodes on themodel of the implantable lead in the graphical user interface.
 19. Themethod of claim 15, further comprising: displaying, via the graphicaluser interface, a virtual control mechanism configured to be engaged bya user, wherein the selectively activating of the first group ofelectrodes or the selectively activating of the second group ofelectrodes is performed in response to an engagement of the virtualcontrol mechanism by the user.
 20. The method of claim 15, furthercomprising: before the refined testing process is performed:determining, based on the coarse testing process, that electrodeslocated in the second region offer better therapeutic relief for thepatient than electrodes located outside the second region, wherein therefined testing process is performed in response to the determining; andidentifying, based on the refined testing process, one or moreelectrodes in the second region that offer a best therapeutic relief forthe patient.